Ethics committee, registered with DCGI according to the Drugs & Cosmetics Rules, can also decide whether a site is suitable for conducting these procedures.Prabha Raghavan | ET Bureau | August 11, 2016, 06:00 IST

NEW DELHI: India recently announced a series of steps that may revive clinical research and tests of newly invented drugs here, but health activists say the move may also compromise the safety of the people tested on.

While pharmaceutical companies are cautiously signalling their return to the business, non-governmental organisations advocating against unethical clinical trials may raise the ante against the government's decision.

Earlier this month, the health ministry notified that an investigator handle as many clinical trials as approved by the ethics committee—a reversal from an earlier order that capped the number at three per investigator.

The ethics committee, registered with the Drugs Controller General of India (DCGI) according to the Drugs & Cosmetics Rules, can also decide whether a site is suitable for conducting these procedures.

Lauding the decision, the Organisation of Pharmaceutical Producers of India (OPPI), a lobby group of research-based pharma companies in India, said it will expedite the process of clinical trials and create an environment conducive to research and innovation here.

The group also welcomed the decision to remove restrictions on hospitals with less than 50 beds to undertake such trials.

But activist groups such as patient rights NGO Swasthya Adhikar Manch see the new regulations as mostly one-sided.

The new regulations seek to promote pharma companies rather than uphold public interest, according to Amulya Nidhi, the forum's co-convener.

They don’t provide for important quality checks like criteria to select the researcher or investigator conducting the trial or punitive provisions against those found conducting unethical trials, he told ET.

There are also currently no rules to prevent members of the ethics committee from conducting clinical trials—a loophole that could lead to a conflict of interest, Nidhi added.

Without a proper enforcement system from the government’s side, such changes could lead to more deaths and adverse reactions on the subjects used for these trials, he said. “In the present form, the government doesn’t have the capacity to allow more clinical trials. You can’t strengthen clinical research at the cost of the lives of the subjects.”

Swasthya Adhikar Manch said it also intends to discuss the latest changes in the Supreme Court, where its public interest litigation on clinical trials — filed in 2011 — is still being heard. The body expects the government to file an affidavit on the new rules at the apex court.

The group’s key contention centres around trials performed on patients without informed consent and compensation to those affected due to adverse events related to clinical tests.

In 2013, the Supreme Court directed the government to put a mechanism in place to monitor trials of untested drugs developed by multinational pharma companies.

The number of clinical trials in India shot up around to 500 in 2010 from 65 in 2008, according to data from the Central Drugs Standard Control Organisation. Approvals dropped drastically 2011 onwards following the Supreme Court's intervention and only 39 trials have been approved so far in 2016.